15 PROTOCOLS

There are no minimal, federally approved standards governing the education, training and privileging of medical practitioners of ECT. Further, there are no federally approved standards for required protocols to ensure the safety and efficacy of ECT. In effect, this has resulted in the implementation of a patchwork of protocols across the nation. The efficacy of ECT and the impacts on patient safety can be significant if certain equipment, protocols and procedures are used. Yet, the 1985 NIH Consensus Statement regarding ECT did not include specific recommendations for ECT protocols, nor does the APA's 2001 Task Force report outline or advocate for mandatory safeguard requirements. On the contrary, the APA's report identifies suggested protocols for voluntary implementation, which does not provide the assurance necessary to protect the health and safety of ECT patients.

NIH CONSENSUS STATEMENT, JUNE, 1985

An area location should be designated for the treatment of ECT and for supervised medical recovery from the treatment. This area should have appropriate health care professionals available and include equipment and other medications that could be used in the event of cardiopulmonary or other complications resulting from the procedure (NIH, p. 9).

2001 APA TASK FORCE REPORT

ECT is a complex procedure that requires a Well-trained, competent staff of professionals if it is to be administered in a safe and effective fashion.

ECT training in residency programs in the United States ranges from excellent to totally absent. In many cases, training is no more than minimal.

No national accrediting body presently provides assurance of competence in ECT. Accordingly clinical competency of practitioners is presently ensured through local privileging.

Each member of the ETC team should be clinically privileged to practice his or her respective ECT duties or be otherwise authorized by law to do so.

It is clear that general privileging in psychiatry will not suffice and that specific clinical privileges to administer ECT should be required.

It is incumbent on facilities using ECT to implement and monitor compliance with reasonable and appropriate policies and procedures.

ECT facilities should be appropriately equipped and staffed with personnel to manage potential clinical emergencies.

A variety of devices to administer ECT are in use.

There is evidence that disruption of the EEG is more profound with sine wave stimulation. Consequently, the continued use of sine wave stimulation in ECT is not justified.

ECT devices also differ in whether they operate on principles of constant current. constant voltage or constant energy.

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No conceptual justification exists for the use of a constant voltage device in ECT.

There is no conceptual justification for the use of a constant energy device in ECT.

Device manufacturers should provide detailed descriptions of testing procedures and preventative maintenance instructions.

As with other medical devices, a regular schedule of retesting or recalibration by biomedical engineers or other qualified professionals should be implemented.

Electrode placement affects the breadth, severity and duration of cognitive side effects. Bilateral ECT produces more short and long term adverse cognitive effects than right unilateral ECT.

The extent to which practitioners use unilateral or bilateral ECT varies considerably.

The choice of stimulus dosing strategy should consider that initial seizure threshold may vary widely among patients and generally increases over the treatment course.

The choice of stimulus dosing strategy should also consider that therapeutic and adverse effects might vary depending upon the extent to which the stimulus intensity exceeds the seizure threshold.

Before the muscle relaxant is administered, a blood pressure cuff should be inflated. Use of the cuff procedure allows for timing of unmodified convulsive movements without risk to the patient.

At a minimum, one channel of EEG activity should be monitored with a paper record or auditory output.

INFORMATION ABOUT ECT, OFFICE OF MENTAL HEALTH, 2001

In July 2001, OMH submitted written information to the Committee regarding ECT. This OMH document states:

In order to maximize effectiveness and minimize side-effects, OMH is committed to ensuring that practitioners administering ECT in New York State follow the latest (second edition, 200 1) guidelines published by the American Psychiatric Association (APA) Task Force on ECT. CIMH psychiatric centers which provide ECT adhere to the APA's Guidelines regarding its administration.

Two of the guidelines cited in this document were:

1. Procedures for obtaining written consent for the administration of ECT for patients who possess the capacity to consent

2. Staff requirements, including medical disciplines, privileging, training and specific treatment responsibilities

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While OMH acknowledges that APA suggested guidelines are worthy of adherence and assert they are being abided by OMH psychiatric centers, unless OMH establishes stringent mandates requiring such conformity, providers of ECT treatment will not consistently apply the use of these parameters statewide. Again, the APA's guidelines are recommendations, not required mandates.

ECT PRACTICES IN THE COMMUNITY (an unpublished report)

The 59 facilities surveyed varied considerably in many aspects of ECT practice: stimulus waveform, electrode placement, stimulus dosing, primary anesthetic agent, physiological monitoring, frequency of cognitive assessment, and so on .... In a number of instances, the practices reported by the facilities clearly departed from the 'standards' in the field .... Finally. this study did not audit actual practices, but relied on the report of the Directors of ECT Services. Concerned about the correspondence between the reports and actual patterns of practice, we also reviewed the medical charts ... When discrepancies were found between the survey results and the review of the medical records, they were consistently in the direction of... the reports by the ECT service directors being more in line with guideline recommendations than actual practices of the facilities (pgs. 8-9).

The report found:

The forms of ECT administered varied widely.

EEG monitoring was not used in 14% of the facilities.

Monitoring of the motor seizure with the cuff technique was not conducted in 53% of the facilities.

Approximately 11% of patients received sine wave stimulation.

Approximately 75% of patients were treated with bilateral ECT.

The primary strategy was fixed dosages at 11 facilities.

Nine facilities reported some use of multiple-monitored ECT, in which more than one seizure is evoked in a session.

SURVEY OF THE PROVISION OF ELECTRO-CONVULSIVE THERAPY (ECT) AT NEW YORK STATE PSYCHIATRIC CENTERS BY THE COMMISSION ON QUALITY OF CARE, AUGUST 7,2001

The CQC survey determined that protocols varied in detail regarding the procedure itself, as well as in issues such as physician privileging and determining capacity to consent. The CQC report stated, "While all facilities have policies and procedures in place governing the use of ECT, policies regarding the credentialing of physicians and addressing informed consent varied widely" (pg. 5).

The CQC recommended that OMH establish a Blue Ribbon Task Force charged with the responsibility of developing ECT protocols that can be consistently applied in state facilities administering ECT and which promote the application of best practices while ensuring strict adherence to statutory and regulatory standards for safeguarding patient rights. In response, OMH stated that, in January 2001. the

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Office began reviewing an ECT checklist that had been used by State psychiatric centers administering ECT for the prior two-year period. OMH also stated it had drafted guidelines for consistent ECT administration and was planning to submit these guidelines to the APA and HANYS (Health Association of NYS) for review.

On October 11, 2001 Assembly Mental Health Committee Chair, Martin Luster, wrote to OMH Commissioner Stone. Chairman Luster's correspondence requested specifics including the following:

In chairing two public hearings on ECT. I have come to recognize the wide range of opinions regarding the efficacy and best practices relative to the administration of ECT. I am interested to know what measures you have taken to ensure OMH's in-house review will address the broad scope of issues that exist and include the varying opinions that a blue ribbon task force would be charged with addressing. Could you please provide me with an update on your progress with regard to OMA's in-house review of ECT policies and a copy of OMH's draft guidelines for state facilities administering ECT, with a list of individuals consulted in the drafting of these guidelines? A complete understanding of your goals, how you intend to achieve these goals, and your progress in this task will be helpful to me in determining whether an independent task force, such as suggested by the CQC, remains necessary.

On November 6. 200 1, OMH Commissioner James Stone responded. He stated:

OMH's review found that equipment and administration of ECT in our state-operated hospitals complies fully with these APA guidelines. One area where further refinement was recommended concerned informed consent and procedures .... Concerning ECT administration on the community side, my staff ... have developed draft guidelines ... The most representative means of reviewing these guidelines will be to submit them to the Mental Health Services Council for review and comment ... Once the Council has had the chance to review these draft guidelines, I will be happy to share them with you, along with a list of the committee members who developed this document.

While the Committee recognizes that OMH is conducting an in-house review of applicable guidelines, it is apparent based upon the Commissioner's response that such review will not include all of the issues identified by the Committee. Furthermore. though OMH's planned process will help foster and facilitate a timely discussion and review of protocols by a knowledgeable advisory body, it appears it will be depending largely upon input from an organization lacking the requisite expertise regarding issues relating to ECT. More specifically, the Committee acknowledges the Mental Health Services Council's contributions to the field as an organization representing a diversified mental health constituency. However, MHSC is not a professionally based entity comprised of persons with specific expertise on medical consent and/or in the establishment of medical related guidelines. Therefore, it is recommended that OMH expand its review process to ensure it comprehensively examines the issues and concerns raised by the Committee, and solicits feedback from varying constituencies with expertise in the areas under consideration.

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